Pay-it-forward Gonorrhea and Chlamydia Testing Among Men in China

NCT05723263 | Completed Results

• 2 other identifiers: 21-1667R01AI158826
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

PIONEER is a three-arm, programmatic cluster randomized controlled trial (RCT) to compare effectiveness of three implementation strategies, followed by a mixed-methods implementation evaluation study

Conditions

Gonorrhea; Chlamydia

Keywords

gonorrhea; sexually transmitted infection (STI); gonorrhea testing among men who have sex with men; chlamydia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Testing for Gonorrhea and Chlamydia

  Defined as the number of eligible participants who accepted and provided laboratory samples for gonorrhea and chlamydia PCR testing out of the total number of eligible participants recruited across the three study arms.

  During enrollment visit

Secondary Outcomes (8)

• Donation Amount

  Baseline

• Number of Participants Who Test Positive for Gonorrhea

  Within 2 weeks of enrollment

• Number of Participants Who Test Positive for Chlamydia

  Within 2 weeks of recruitment

• Cost Per Test Per Individual

  Baseline - During enrollment visit

• Mean Self Reported Gratitude Score

  During enrollment visit

Other Outcomes (3)

• Gonorrhea and Chlamydia Testing Uptake by Clinic Type

  During enrollment visit

• Gonorrhea and Chlamydia Testing Uptake by Sexual Orientation

  During enrollment visit

• Gonorrhea and Chlamydia Testing Uptake by Age Group

  During enrollment visit

Study Arms (3)

Standard Pay-it-forward

EXPERIMENTAL

* free gonorrhea/chlamydia testing * minimal engagement

Behavioral: Standard Pay-it-forward

Community engaged Pay-it-forward

EXPERIMENTAL

* Free gonorrhea/chlamydia testing * Stronger engagement

Behavioral: Community Engaged Pay-it-forward

Control arm

OTHER

* Test available for a fee * No engagement

Other: Control arm

Interventions

Standard Pay-it-forward BEHAVIORAL

400 men who have sex with men (MSM) at 4 clinics will be enrolled. The standard pay-it-forward arm will include free point-of-care gonorrhea testing, as well as a passive community engagement component (such as viewing postcards and materials written by others encouraging gonorrhea/chlamydia testing).

Standard Pay-it-forward

Community Engaged Pay-it-forward BEHAVIORAL

400 MSM at 4 clinics will be enrolled. The community engaged pay-it-forward arm will include free point-of-care gonorrhea testing, as well as an active community engagement component (such as multi-stakeholder co-creation activities to develop essential components of the intervention and implementation strategies; writing postcards; designing fans with stickers; sending out testing promotion messages on social media; and opportunity to donate to support others)

Community engaged Pay-it-forward

Control arm OTHER

400 MSM at 4 clinics will be enrolled. The control arm will include a fee-based point-of-care gonorrhea testing (approximately 20 U.S. Dollars (USD) per test) and no community engagement component

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years old
• have had sex over the past year
• have not been tested for gonorrhea and chlamydia in the past year
• reside in the city in the past three months
• speak Mandarin Chinese or Cantonese
• mentally capable of providing informed consent to test for gonorrhea and chlamydia
• own a mobile phone

You may not qualify if:

• \< 18 years of age

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Dermatology Hospital, Institute for Global Health and Sexually Transmitted Diseases, Southern Medical University, China

Guangzhou, Guangdong, 510095, China

Location

Related Publications (2)

• Liu Y, Zhou K, Li L, Salma G, Fitzpatrick T, Marley G, Zhu Z, Tang W, Tucker JD. Financing STI testing among men in China: A mixed-methods study of pay-it-forward monetary donations. PLoS One. 2026 Feb 13;21(2):e0342595. doi: 10.1371/journal.pone.0342595. eCollection 2026.

  PMID: 41686825 DERIVED

• Marley G, Tan RKJ, Wu D, Wang T, Sun M, Sheng Q, Holly ME, Hlatshwako TG, Wang C, Tang W, Ramaswamy R, Yang L, Luo D, Sylvia SS, Gray K, Van Duin D, Zheng H, Tucker JD. Pay-it-forward gonorrhea and chlamydia testing among men who have sex with men and male STD patients in China: the PIONEER pragmatic, cluster randomized controlled trial protocol. BMC Public Health. 2023 Jun 20;23(1):1182. doi: 10.1186/s12889-023-16095-8.

  PMID: 37337181 DERIVED

MeSH Terms

Conditions

Gonorrhea; Chlamydia Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Chlamydiaceae Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joseph Tucker, MD, PhD
• Organization: University of North Carolina at Chapel Hill

jdtucker@med.unc.edu

919-966-2536

Study Officials

• Joseph D Tucker, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: hybrid effectiveness-implementation study design

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 10, 2023
• Study Start: April 1, 2023
• Primary Completion: July 15, 2024
• Study Completion: September 30, 2024
• Last Updated: December 3, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: Investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

CN (1)